US EPA, Tolerance Reassessment Advisory Committee

Note: This information is provided for reference purposes only. Although the information provided here was accurate and current when first created, it is now outdated.

TRAC 5/27/98

APPENDIX 2

OVERVIEW OF RESIDUE CHEMISTRY DATA REQUIRED
FOR THE REGISTRATION OF PESTICIDE CHEMICALS

PLEASE NOTE: The full unabridged data requirements may be found at 40 CFR 158.240. The material provided in this document is merely intended to provide a 'plain-english' guide to the residue chemistry requirements.

Residue chemistry data are used by the Agency to estimate the exposure of the general U.S. population to pesticide residues in food, and in turn, for setting and enforcing tolerances for pesticide residues in food or feed. Information on the chemical identity and composition of the pesticide product, the amounts, frequency and time of application, and results of tests on the amount of residues remaining on or in the treated food or feed, are needed to support a finding as to the magnitude and identity of residues which result in food or animal feed as a consequence of a proposed pesticide usage. Residue chemistry data are also needed to support the adequacy of one or more methods for the enforcement of the tolerance, and to support practicable methods for removing residues that exceed any proposed tolerance.

Provided in the first two tables (i.e., 'The Basic Data Set' and 'Other Studies Required') are the actual nuts&bolts data that registrants must submit to the Agency for food uses of pesticides. The difference between these two tables is that the 'Basic Data Set' lists the studies that under most cases are always required for food uses; the next table provides the additional studies that must be provided if a certain condition is met. The third table shows the 'written' or compiled data requirements - the 'Odds and Ends' that are not really precise measurements like the data requirements in the first two tables but rather miscellaneous descriptors and facts.

The Basic Data Set

DATA REQUIREMENT (Test And Guideline #)		WHAT DO THE DATA TELL US?
Residue Analytical Method (171-4)		What analytical method will be able to detect and quantify the pesticide and its metabolites?
Multiresidue Method (171-4)		Whether or not the FDA/USDA multiresidue methodology would detect and quantify the pesticide and its metabolites.
Chemical Identity (171-2)		Chemically, what IS this pesticide? What are the impurities?
Directions for Use (171-3)		Which crops is the pesticide used on? What's the application rate? How many applications,etc? What's the formulation?
Nature of the Residue - Plants (171-4)		How is the pesticide metabolized in plants? What are the metabolites and their relative proportions in the edible portions of the plant? Are the metabolites of toxicological "concern"?
Nature of the Residue - Livestock (171-4)		How is the pesticide metabolized in animals? Are the metabolites of toxicological "concern"?
Magnitude of the Residue	Storage Stability Data (171-4)	Are the residues in the frozen matrix stable? What percentage of the residue is 'lost'?
	Crop Field Trials (171-4)	"Farm Gate" levels of pesticide residues on food. These are 'worst-case' levels of the potential amount of pesticide that may remain on food when it is harvested. In crop field trials, the pesticide under investigation is applied at the maximum label rate, for the maximum number of applications and the crop is harvesting at the minimum pre-harvest interval. Also, crop fields must be conducted in the appropriate geographical region(s). Crop Field Trial data are the heart of the residue chemistry requirements.

Other Studies Required

CONDITION	DATA REQUIREMENT		WHAT DOES IT TELL US?
Pesticide Could Concentrate Upon Processing.	MAGNITUDE OF THE RESIDUE	Processed Food/ Feed (171-4)	Whether residues in raw commodities may be expected to degrade or concentrate during food processing (e.g., grapes being processed to raisins).
Pesticide Is Present on Livestock Feed Items.		Meat/Milk/ Poultry/Eggs (171-4)	The level of pesticide that is transferred to food items through the animals who have consumed feed containing pesticide residues.
Pesticide is Applied Directly to Drinking Water.		Water (171-4)	These studies are used by the Agency to determine the levels of pesticide residues in water, fish, and irrigated crops when products are applied directly to water to control aquatic pests such as weeds or insects (e.g., hydrilla, mosquitoes). The data are used in dietary risk assessment and, in the case of fish and irrigated crops, to establish tolerances for enforcement purposes.
Pesticide Is Applied Directly to Water Inhabited by Fish.		Fish (171-4)
Pesticide Is to Be Applied Directly to Water That Could Be Used for Irrigation.		Irrigated Crops (171-4)
Pesticide Is to Be Used Food-Handling Establishments		Food Handling (171-4)	The level of pesticide in food or feed resulting from treatment of food/feed handling establishments with pesticides.
Crops are to be rotated.	Confined Rotational Crops (165-1)		These data enable the Agency to determine the nature and amount of pesticide residue uptake in rotational crops. "Confined" means that the study is conducted on a small 'confined' plot, using radioactive material.
Residues of the parent pesticide are found in the confined rotational crop study.	Field Rotational Crops (165-2)		The purpose of field studies is to determine the amount of pesticide residue uptake into rotational crops. These studies are done on field plots.

Odds and Ends

DATA REQUIREMENTS

(Test And Guideline #)
WHAT DO THE DATA TELL US?

Anticipated Residues (171-5) Anticipated Residues (ARs) can be thought of as "dinner plate" levels of pesticide residues in food. They are the Agency's best estimate of actual residue in foods, as consumed. ARs can take into account: the percent of the crop that is treated; actual application rates and use patterns; loss of pesticide residue as the crop is stored, processed, and transported; and consumer practices such as washing, peeling, and cooking. Generally speaking, ARs are not something that the Agency requires registrants to submit. Rather, EPA will calculate them using available information. However, the registrants may submit ARs if they wish.

Proposed Tolerance (171-6) Based on the results of field trials, what would be an appropriate tolerance?

Reasonable Grounds in Support

of the Petition (171-7)
The rationale of how the residue data support the proposed tolerance.

Submittal of Analytical Reference Standards (171-13) Submittal of analytical reference standards provides assurance that proper analytical reference grade materials are available for the Agency to validate residue and environmental chemistry analytical methods and that Federal and State enforcement laboratories have a known consistent source of analytical reference standards to validate methods employed in enforcement and monitoring activities.

DATA REQUIREMENTS (Test And Guideline #)	WHAT DO THE DATA TELL US?
Anticipated Residues (171-5)	Anticipated Residues (ARs) can be thought of as "dinner plate" levels of pesticide residues in food. They are the Agency's best estimate of actual residue in foods, as consumed. ARs can take into account: the percent of the crop that is treated; actual application rates and use patterns; loss of pesticide residue as the crop is stored, processed, and transported; and consumer practices such as washing, peeling, and cooking. Generally speaking, ARs are not something that the Agency requires registrants to submit. Rather, EPA will calculate them using available information. However, the registrants may submit ARs if they wish.
Proposed Tolerance (171-6)	Based on the results of field trials, what would be an appropriate tolerance?
Reasonable Grounds in Support of the Petition (171-7)	The rationale of how the residue data support the proposed tolerance.
Submittal of Analytical Reference Standards (171-13)	Submittal of analytical reference standards provides assurance that proper analytical reference grade materials are available for the Agency to validate residue and environmental chemistry analytical methods and that Federal and State enforcement laboratories have a known consistent source of analytical reference standards to validate methods employed in enforcement and monitoring activities.